Real-world response monitoring and tolerability of imatinib-treated chronic myeloid leukemia patients captured in a retrospective research registry.

6583 Background: Monitoring tolerability and response to imatinib (IM) is an important aspect of chronic myeloid leukemia (CML) management. The objective of this study is to assess real-world tolerability and response monitoring in IM treated CML patients (pts). Methods: A comprehensive retrospective outcomes research registry of CML pts was created from the University of Utah electronic health record system. Study inclusion was limited to pts diagnosed with CML in chronic phase in 2001 to 2010 and treated with IM as a first-line therapy. Utilization and outcome of cytogenetic and molecular testing within 18 months of IM initiation, rates of adverse drug events (ADEs), and therapy modifications were evaluated by chart review. Results: A total of 92 pts were treated with IM as first-line therapy. Within the first 18 months of treatment, cytogenetic testing was recorded in 45 pts (49%) and of these 33 pts (73%) achieved a complete cytogenetic response (CCyR) in a median of 241 days (range: 110-542); molecular testing was completed in 48 pts (52%) and of these 24 pts (50%) achieved at least a major molecular response (MMR) in a median of 254 days (range: 99-546). Imatinib associated ADEs of any grade (n = 60) occurred in 42 (46%) pts resulting in dose reductions in 15 pts (36%) in a median of 77 days and discontinuation of IM occurred in 9 (21%) pts in a median of 130 days. The IM dose was increased to >400 mg in 21 (23%) pts in a median of 457 days (range: 21-2112). Of pts diagnosed between 2006 to 2010 (n = 34; 37%), 8 (25%) pts transitioned to dasatinib or nilotinib in a median of 397 days (range: 147 to 1057). Reasons for therapy change included physician documented suboptimal response or treatment failure (n = 5) and ADEs to IM (n = 3). Conclusions: Utilization of cytogenetic and molecular testing within 18 months of IM initiation was lower than the National Comprehensive Cancer Network or European LeukemiaNet CML guidelines would suggest. Further research is warranted to understand limited response monitoring and outcomes in non-monitored pts. The ADE rate was similar to clinical trial data. The impact of ADEs on subsequent treatment and outcomes in CML pts deserves further study.

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Clinical significance of dasatinib-induced pleural effusion in patients with de novo chronic myeloid leukemia

Hematology Reports ◽

10.4081/hr.2018.7474 ◽

2018 ◽

Vol 10 (3) ◽

Cited By ~ 1

Author(s):

Aya Nakaya ◽

Shinya Fujita ◽

Atsushi Satake ◽

Takahisa Nakanishi ◽

Yoshiko Azuma ◽

...

Keyword(s):

Chronic Myeloid Leukemia ◽

Clinical Features ◽

Myeloid Leukemia ◽

De Novo ◽

Late Onset ◽

Molecular Response ◽

First Line ◽

First Line Therapy ◽

Line Therapy ◽

Treatment Agent

Dasatinib is currently approved for clinical use as a first-line treatment agent for newly diagnosed chronic myeloid leukemia (CML). However, only a few clinical trials have been performed to evaluate dasatinibinduced PE following first-line therapy. We investigated the incidence and clinical features of dasatinib-induced PE following first-line therapy in Japanese CML patients of real world clinical practice settings. Among 22 patients, the median age of PEpositive patients was higher than that of PEnegative patients. Major molecular response was achieved in 75% of PE-positive patients and 50% of PE-negative patients. Most patients developed PE more than 1 year after treatment. Appearance of PE is associated with better clinical response during dasatinib treatment, however it is developed at any time. Elderly and high-risk patients tend to develop PE. The clinical features of dasatinib-induced PE following first-line therapy might be late onset and might not immediately follow the increasing of large granular lymphocyte.

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Predictive value of early molecular response in patients with chronic myeloid leukemia treated with first-line dasatinib

Blood ◽

10.1182/blood-2012-01-407486 ◽

2012 ◽

Vol 120 (2) ◽

pp. 291-294 ◽

Cited By ~ 98

Author(s):

David Marin ◽

Corinne Hedgley ◽

Richard E. Clark ◽

Jane Apperley ◽

Letizia Foroni ◽

...

Keyword(s):

Chronic Myeloid Leukemia ◽

Predictive Value ◽

Myeloid Leukemia ◽

Transcript Level ◽

Cytogenetic Response ◽

Molecular Response ◽

First Line ◽

Complete Cytogenetic Response ◽

First Line Therapy ◽

Line Therapy

Abstract Dasatinib is effective therapy for newly diagnosed patients with chronic myeloid leukemia, but not all patients respond well. We analyzed the outcome of patients treated with dasatinib as first-line therapy to identify patients who are more likely to fare poorly. The 8.6% of patients who at 3 months had a BCR-ABL1/ABL1 ratio > 10% had a significantly worse 2-year cumulative incidence of complete cytogenetic response (58.8% vs 96.6%, P < .001) and molecular responses than the remaining patients with a lower transcript levels. The predictive value of the 3-month transcript level could be improved using the dasatinib-specific transcript level cut-offs, namely, 2.2%, 0.92%, and 0.57% for complete cytogenetic response, 3 log and 4.5 log reductions in the transcript level, respectively. The study was registered at www.clinicaltrials.gov as #NCT01460693.

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Deep and early molecular response induced by nilotinb in a newly diagnosed patient with chronic myeloid leukemia (CML)

Clinical Management Issues ◽

10.7175/cmi.v7i1s.1144 ◽

2015 ◽

Vol 7 (1S) ◽

pp. 19-23

Author(s):

Antonella Russo Rossi

Keyword(s):

Chronic Myeloid Leukemia ◽

Myeloid Leukemia ◽

Transcript Level ◽

Cytogenetic Response ◽

Molecular Response ◽

First Line ◽

First Line Therapy ◽

Line Therapy ◽

Complete Hematologic Response ◽

Level Reduction

We report a case of a patient with chronic myeloid leukemia diagnosed in January 2012 and treated with nilotinib 600 mg/die as first line therapy. Patient obtained a complete hematologic response (CHR) and improvement of splenomegaly in 2 weeks. In three months the patient obtained complete cytogenetic response (CCR) and an important transcript level reduction (less than 1%). According to the international recommendations, molecular analysis was performed every three months in a LABNET network laboratory. Treatment was never interrupted or reduced due to any adverse event. After 9 months patient achieved a major molecular response (MMR) and during evaluation a MR4 has been documented.

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Efficacy and safety of Bosutinib in Patient with Chronic myeloid leukemia who was intolerant to DASTANIB,NILOTUNIB -Case report

10.22541/au.163081997.76172055/v1 ◽

2021 ◽

Author(s):

Abdullah Mohammad Arshad ◽

mohamed yassin

Keyword(s):

Case Report ◽

Chronic Myeloid Leukemia ◽

Myeloid Leukemia ◽

Chronic Phase ◽

Molecular Response ◽

Efficacy And Safety ◽

Major Molecular Response ◽

First Line ◽

First Line Therapy ◽

Line Therapy

Bosutinib is approved as first line therapy for treatment of chronic phase CML and also in patients who are either resistant or intolerant to previous TKI. We present a 59 year old male who was intolerant to 2 TKI but showed excellent hematological and major molecular response to Bosutinib.

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Clonal chromosomal abnormalities in Philadelphia-negative cells in chronic myeloid leukemia patients treated with nilotinib used in first-line therapy

Annals of Hematology ◽

10.1007/s00277-013-1816-z ◽

2013 ◽

Vol 92 (12) ◽

pp. 1625-1632 ◽

Cited By ~ 6

Author(s):

Huafeng Wang ◽

Jie Jin ◽

Yungui Wang ◽

Xin Huang ◽

Jian Huang

Keyword(s):

Chronic Myeloid Leukemia ◽

Myeloid Leukemia ◽

Chromosomal Abnormalities ◽

First Line ◽

First Line Therapy ◽

Line Therapy

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Medical decision analysis for first-line therapy of chronic myeloid leukemia

Leukemia & Lymphoma ◽

10.3109/10428194.2013.858149 ◽

2014 ◽

Vol 55 (8) ◽

pp. 1758-1767 ◽

Cited By ~ 3

Author(s):

Ursula Rochau ◽

Gaby Sroczynski ◽

Dominik Wolf ◽

Stefan Schmidt ◽

Annette Conrads-Frank ◽

...

Keyword(s):

Chronic Myeloid Leukemia ◽

Decision Analysis ◽

Myeloid Leukemia ◽

Medical Decision ◽

First Line ◽

First Line Therapy ◽

Line Therapy ◽

Medical Decision Analysis

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Treatment Interruption and Regimen Change in Firstgeneration versus Second-generation Tyrosine Kinase Inhibitors used as First-line Therapy for Chronic Myeloid Leukemia

Journal of Health Economics and Outcomes Research ◽

10.36469/9899 ◽

2015 ◽

Vol 2 (2) ◽

pp. 181-191

Author(s):

Melea A. Ward ◽

Gang Fang ◽

Kristy L. Richards ◽

Christine M. Walko

Keyword(s):

Chronic Myeloid Leukemia ◽

Tyrosine Kinase ◽

Myeloid Leukemia ◽

Second Generation ◽

Treatment Interruption ◽

First Line ◽

First Line Therapy ◽

Line Therapy ◽

Treatment Interruptions ◽

Regimen Change

Background: Research has shown that treatment interruptions are associated with worse failure-free survival in chronic myeloid leukemia (CML); however they are commonly used in clinical trials to manage adverse events. Objectives: This study assessed the comparative rates of treatment interruption and regimen change between patients initiating first-line therapy with a first-generation tyrosine kinase inhibitor (1GTKI) imatinib versus second-generation TKI (2GTKI), dasatinib or nilotinib, for the treatment of CML in clinical practice. Methods: This was a retrospective cohort study using the Humana Research Database. Patients with CML who were between the ages of 18 and 89 and newly initiated 1GTKI or 2GTKI therapy between June 1, 2010 and December 31, 2011 were included. Treatment interruption and regimen change were compared using multivariable Cox proportional hazard regression models. Treatment interruption was defined as a gap in any TKI pharmacy claim that was longer than an allowable refill gap plus days’ supply from the previous TKI medication claim. Regimen change was defined as 1) a prescription claim for a different TKI therapy, or 2) increase in dose for the same medication. Results: 368 patients met the inclusion criteria: 1GTKI n=237, 2GTKI n=131. Patients initiating therapy with a 2GTKI had a 48% higher risk of treatment interruption versus patients initiating therapy with a 1GTKI (hazard ratio=1.48, 95% confidence interval 1.08-2.02). The time to treatment interruption was significantly longer in patients initiating therapy with a 1GTKI. Approximately 19% of patients had a regimen change, but there were no differences in rates of regimen changes between the two generations. Conclusions: In this study from a large single health plan population, treatment interruptions were more common among patients initiating therapy with a 2GTKI, yet regimen change rates did not vary by generation of TKI. Future research should assess reasons for treatment interruption and investigate these associations in other populations.

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